The Potential Impact of the Election on the LDT Final Rule 

The election results raise many questions regarding possible shifts in the FDA's enforcement priorities. Throughout the campaign and the transition period, President-Elect Trump and his surrogates have indicated plans to alter FDA enforcement concerning food safety, prescription drugs, and vaccines. There have been no comments regarding devices or diagnostics in general, or LDTs in particular. Nonetheless, the question persists....

How might the new administration alter the current path of LDT regulation?

Christine P. Bump
Principal and Founder
Penn Avenue Law & Policy

Christine Bump is a regulatory attorney with nearly two decades of experience developing and implementing FDA strategies for devices, diagnostics, and digital health platforms. She served as regulatory counsel for a national coalition of diagnostic companies and is a prolific author and speaker in the field. Before establishing her firm, she worked at Goodwin Procter LLP and Hyman, Phelps, and McNamara, P.C. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.